MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. OES HYSTEROFIBERSCOPE

Model Number HYF-XP

Device Problem Device Reprocessing Problem (1091)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

The customer originally returned his olympus oes hysterofiberscope due to spots being noted in the image.There was no patient harm reported as a result of this event.During the device evaluation it was discovered that the subject device had undergone insufficient reprocessing as foreign material was found coming out of the forceps channel.This report is being submitted to capture the insufficient reprocessing confirmed during the device evaluation.

Manufacturer Narrative

The device was returned, and an initial evaluation was conducted by olympus; however, investigation is ongoing.During the initial evaluation, the user¿s report was confirmed.There were stains in the image during testing.Additionally, as noted in b5, the unit had undergone insufficient reprocessing as foreign material was found in the forceps channel.The unit also had peeling adhesive, scratching, corrosion, and general chipping present throughout the device.Following the confirmed reprocessing failure, olympus personnel sent the user facility a reprocessing questionnaire.Through the questionnaire, the user facility confirmed all reprocessing steps in accordance with the instructions for use (ifu).If additional information becomes available following the device evaluation, a supplemental report will be filed.

Manufacturer Narrative

This report is being supplemented to provide information that was inadvertently left out of the initial medwatch and to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.The device met all specifications at the time of shipment.It has been over a year since the subject device was manufactured.Based on the results of the legal manufacturer's investigation, the foreign material could not be identified.Hence, a conclusive root cause could not be determined.The suggested event is preventable by handling the scope in accordance with the following sections of the instructions for use: chapter 5 safety for cleaning, disinfection and sterilization chapter 6 application and condition of cleaning, disinfection and sterilization chapter 7 cleaning, disinfection and sterilization procedures per the legal manufacturer, the other device defects included in the initial medwatch have no potential to cause or contribute to death or serious injury if the malfunctions were to recur.Olympus will continue to monitor field performance for this device.

• Brand Name: OES HYSTEROFIBERSCOPE
• Type of Device: HYSTEROFIBERSCOPE
• Manufacturer (Section D): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima 961-8 061; JA 961-8061
• Manufacturer (Section G): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17479849
• MDR Text Key: 321540014
• Report Number: 3002808148-2023-08078
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 04953170340178
• UDI-Public: 04953170340178
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K891451
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 09/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HYF-XP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2023
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/27/2023
• Initial Date FDA Received: 08/08/2023
• Supplement Dates Manufacturer Received: 09/14/2023
• Supplement Dates FDA Received: 09/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/04/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1